Olmesartan medoxomil combined with hydrochlorothiazide improves 24-hour blood pressure control in moderate-to-severe hypertension

Abstract

Background:

Twenty-four-hour ambulatory blood pressure monitoring (ABPM) has been shown to be more reliable than conventional measurements for hypertension assessment and the associated increased risk of cardiovascular events. Olmesartan/hydrochlorothiazide combination therapy has demonstrated increased blood pressure lowering over 24 hours compared with the component monotherapies. This prespecified pooled analysis of data from two trials investigated the effects of olmesartan/hydrochlorothiazide combination therapy and olmesartan monotherapy on 24-hour blood pressure control in patients with moderate-to-severe hypertension.

Methods:

After 8 weeks’ open-label olmesartan 40 mg monotherapy, uncontrolled patients (mean trough seated blood pressure 90–115/140–180 mmHg and 24-hour mean ambulatory diastolic blood pressure ≥80 mmHg with ≥30% of daytime ambulatory diastolic blood pressure readings >85 mmHg) were randomised to 8 weeks’ double-blind treatment with olmesartan 40 mg or olmesartan/hydrochlorothiazide 20/12.5, 40/12.5 or 40/25 mg (Study 1) or olmesartan/hydrochlorothiazide 20/25 or 40/25 mg (Study 2). This prespecified analysis of ambulatory blood pressure was performed on patients from the full analysis set of pooled studies 1 and 2, restricted to patients who provided at least one valid ABPM measurement at baseline.

Results:

After 8 weeks’ double-blind treatment, reductions in 24-hour, daytime and night-time blood pressure from baseline were observed for all treatment groups. These reductions were dose-dependent, with olmesartan/hydrochlorothiazide 40/25 mg demonstrating the greatest reductions in 24-hour blood pressure from baseline to Week 16 versus olmesartan monotherapy: −14.0/−8.8 vs −2.7/−2.0 mmHg, respectively; p < 0.0001.

Conclusions:

Adding hydrochlorothiazide to olmesartan provides more effective 24-hour blood pressure control versus olmesartan monotherapy in patients with moderate-to-severe hypertension.

Clinical trial registration:

Trial registration: ClinicalTrials.gov identifier: NCT00430508.

Trial registration: ClinicalTrials.gov identifier: NCT00430950.

Keywords::

• Ambulatory blood pressure monitoring
• Fixed dose combination
• Hypertension
• Olmesartan medoxomil

Transparency

Declaration of funding

This analysis and the two clinical studies investigated were supported by Daiichi Sankyo Europe GmbH.

Declaration of financial/other relationships

D.R. has disclosed that he has no significant relationships with or financial interests in any commercial companies related to this study or article. X.G. has received honoraria from sanofi-aventis, Daiichi-Sankyo, IPSEN, Novartis Pharma, and Boehringer Ingelheim France during the past 3 years.

Acknowledgements

Medical writing services from Amy McCallum of inScience Communications, a Wolters Kluwer business, were funded by Daiichi Sankyo Europe GmbH.